Adalimumab biosimilars in the therapy of Crohn´s disease and
ulcerative colitis: Prospective multicentric clinical
monitoring

J 2022

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA et. al.

Basic information

Original name

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

Authors

WASSERBAUER, Martin (203 Czech Republic), Stepan HLAVA (203 Czech Republic, guarantor), Jiri DRABEK (203 Czech Republic), Jan STOVICEK (203 Czech Republic), Petra MINARIKOVA (203 Czech Republic), Lenka NEDBALOVA (203 Czech Republic), Tomas DRASAR (203 Czech Republic), Zdena ZADOROVA (203 Czech Republic), Jiří DOLINA (203 Czech Republic, belonging to the institution), Štefan KONEČNÝ (703 Slovakia, belonging to the institution), Vladimír KOJECKY (203 Czech Republic), Jana KOZELUHOVA (203 Czech Republic), Pavlina CERNIKOVA (203 Czech Republic), Dita PICHLEROVA (203 Czech Republic), Barbora KUCEROVA (203 Czech Republic), Stepan COUFAL (203 Czech Republic) and Radan KEIL (203 Czech Republic)

Edition

PLOS One, SAN FRANCISCO, PUBLIC LIBRARY SCIENCE, 2022, 1932-6203

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30219 Gastroenterology and hepatology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.700

RIV identification code

RIV/00216224:14110/22:00128066

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1371/journal.pone.0271299

UT WoS

000922632200001

Keywords in English

adalimumab biosimilars; Crohn´s disease; ulcerative colitis

Abstract

V originále

Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Material and methods Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn’s disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. Results In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. Conclusions This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.

Citovat

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA, Lenka NEDBALOVA, Tomas DRASAR, Zdena ZADOROVA, Jiří DOLINA, Štefan KONEČNÝ, Vladimír KOJECKY, Jana KOZELUHOVA, Pavlina CERNIKOVA, Dita PICHLEROVA, Barbora KUCEROVA, Stepan COUFAL and Radan KEIL. Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. PLOS One. SAN FRANCISCO: PUBLIC LIBRARY SCIENCE, 2022, vol. 17, No 8, p. 1-13. ISSN 1932-6203. Available from: https://dx.doi.org/10.1371/journal.pone.0271299.

@article{2247519,
   author = {Wasserbauer, Martin and Hlava, Stepan and Drabek, Jiri and Stovicek, Jan and Minarikova, Petra and Nedbalova, Lenka and Drasar, Tomas and Zadorova, Zdena and Dolina, Jiří and Konečný, Štefan and Kojecky, Vladimír and Kozeluhova, Jana and Cernikova, Pavlina and Pichlerova, Dita and Kucerova, Barbora and Coufal, Stepan and Keil, Radan},
   article_location = {SAN FRANCISCO},
   article_number = {8},
   doi = {http://dx.doi.org/10.1371/journal.pone.0271299},
   keywords = {adalimumab biosimilars; Crohn´s disease; ulcerative colitis},
   language = {eng},
   issn = {1932-6203},
   journal = {PLOS One},
   title = {Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring},
   url = {https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299},
   volume = {17},
   year = {2022}
}

TY  - JOUR
ID  - 2247519
AU  - Wasserbauer, Martin - Hlava, Stepan - Drabek, Jiri - Stovicek, Jan - Minarikova, Petra - Nedbalova, Lenka - Drasar, Tomas - Zadorova, Zdena - Dolina, Jiří - Konečný, Štefan - Kojecky, Vladimír - Kozeluhova, Jana - Cernikova, Pavlina - Pichlerova, Dita - Kucerova, Barbora - Coufal, Stepan - Keil, Radan
PY  - 2022
TI  - Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring
JF  - PLOS One
VL  - 17
IS  - 8
SP  - 1-13
EP  - 1-13
PB  - PUBLIC LIBRARY SCIENCE
SN  - 19326203
KW  - adalimumab biosimilars
KW  - Crohn´s disease
KW  - ulcerative colitis
UR  - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299
N2  - Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Material and methods Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn’s disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. Results In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. Conclusions This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.
ER  -

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA, Lenka NEDBALOVA, Tomas DRASAR, Zdena ZADOROVA, Jiří DOLINA, Štefan KONEČNÝ, Vladimír KOJECKY, Jana KOZELUHOVA, Pavlina CERNIKOVA, Dita PICHLEROVA, Barbora KUCEROVA, Stepan COUFAL and Radan KEIL. Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. \textit{PLOS One}. SAN FRANCISCO: PUBLIC LIBRARY SCIENCE, 2022, vol.~17, No~8, p.~1-13. ISSN~1932-6203. Available from: https://dx.doi.org/10.1371/journal.pone.0271299.

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